SAN FRANCISCO – OCTOBER 26, 2025 – Results from the first randomized clinical trial in the United States to compare a sirolimus-eluting balloon (DEB) to control group consisting of drug-eluting stent (DES) and balloon angioplasty (BA) for the treatment of bare-metal and DES in-stent restenosis (ISR) deemed DEB to be noninferior to conventional therapies.
Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
ISR after DES implantation occurs in 4-8% of patients within one year and continues in over 1% of patients annually. In addition, more than 10% of PCI is due to ISR. The approach to treatment of ISR includes the use of DES, DEB, BA, or coronary artery bypass surgery. However, there are limited randomized data examining the use of drug-coated balloons compared with other conventional approaches for ISR, and no approved sirolimus-eluting balloons in the United States.
In this prospective, international, randomized, single-blind clinical trial, the SELUTION Sustained Limus Release DEB was compared with a blended standard of care (SOC) control group consisting of 80% DES and 20% BA for treatment of ISR with up to two layers of previously implanted bare-metal or DES. The SOC was designed to mirror device use in the NCDR registry at the time of study design. A total of 418 patients were randomized to DEB (n=210) or blended SOC (n= 208, 165 DES and 43 PBA). The mean age was 68.9±9.1 years including 94 (22.5%) female patients, 179 (42.8%) had diabetes and 83 (19.9%) had two layers of previous stent.
The primary endpoint was target lesion failure (TLF) consisting of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at one-year. TLF occurred in 15.2% of the group randomized to DEB compared with 13.5% in the blended SOC group [Difference = 1.8%, 95% Credible Interval (-4.9% – 8.5%), Posterior Probability for noninferiority: 99.18%] by intention-to-treat. Rates of cardiac death (1.9% vs 1.4%), target vessel myocardial infarction (7.1% vs. 4.8%), and clinically driven target lesion revascularization (11.9% vs. 11.5%) were not statistically different between study arms.
"SELUTION DEB is the first and only drug-eluting balloon to demonstrate non-inferiority against the standard of care, including 80% drug-eluting stents, for the treatment of in-stent restenosis," said Donald Cutlip, MD, Interventional Cardiologist at Beth Israel Deaconess Medical Center. "It is a safe and effective ISR treatment which avoids additional layers of stent, and we look forward to the long-term follow-up data."
The study was funded by M.A. Med Alliance SA (a Cordis Company).
Dr. Cutlip reported grant/research support from Cordis (MedAlliance) and Corvia Medical as well as consultant fees/honoraria from Boston Scientific.
The results of the study were presented on Sunday, October 26, 2025, at 11:22 a.m. PT in the Main Arena (Hall A, Exhibition Level, Moscone South) at the Moscone Center during TCT 2025.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is a global leader in interventional cardiovascular medicine, driving innovation, spearheading groundbreaking research, and transforming education in the field. Through its relentless pursuit of excellence, CRF not only accelerates medical breakthroughs but also equips healthcare professionals with the tools and knowledge necessary to enhance survival rates and elevate the quality of life for millions worldwide. CRF's centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Anchored in a legacy spanning over three decades, TCT is a world-class educational experience featuring disruptive innovation, scientific breakthroughs, expert-led tutorials, hands-on training, and ample opportunities for networking and collaboration.
